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RegisterSustained release formulations BE [Design Issues]
Dear Dr. Helmut
Kindly advise me how to conduct BE for a sustained release formulation in UK/EU. Both the innovator and test products are sustained release formulation of same strength. Whether the studies have to be conducted in s.s.a designs. Whether Both fasting and fed BE has to be conducted. Whether BW can be applied based on the highest dose strength if IVIVC performed. If IVIVC has to be performed on what method. is it by Wagner or Loo - Reigelmann method (but no oral solution data is available) or numerical deconvulation method to be used. Kindly clarify
Sincerly,
D.Ahmed
Kindly advise me how to conduct BE for a sustained release formulation in UK/EU. Both the innovator and test products are sustained release formulation of same strength. Whether the studies have to be conducted in s.s.a designs. Whether Both fasting and fed BE has to be conducted. Whether BW can be applied based on the highest dose strength if IVIVC performed. If IVIVC has to be performed on what method. is it by Wagner or Loo - Reigelmann method (but no oral solution data is available) or numerical deconvulation method to be used. Kindly clarify
Sincerly,
D.Ahmed
Complete thread:
- Sustained release formulations BEAhmed meeran 2006-11-21 12:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sustained release formulations BE velupharm 2006-11-30 09:54
Ing. Helmut Schütz